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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I GAS-MACHINE, ANESTHESIA

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MAQUET CRITICAL CARE AB FLOW-I GAS-MACHINE, ANESTHESIA Back to Search Results
Model Number FLOW-I C30
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

It was reported that the machine leaked and self-triggered. Additional information states that the user had mounted the patient cassette in the anesthesia workstation in an incorrect way. This led to leakages and self-triggering. No part needed to be replaced and there was no device malfunction. No device logs have been available to confirm the event. A simulated use test was performed on a reference device. The test showed that a patient cassette not properly mounted will be detected in system check out and/or leakage check.

 
Event Description

It was reported that the the machine leaked and self-triggered. There was no patient harm. Manufacturer´s ref #: (b)(4).

 
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Brand NameFLOW-I
Type of DeviceGAS-MACHINE, ANESTHESIA
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
roentgenvagen 2
solna
Manufacturer (Section G)
MAGNUS LINDQVIST
maquet critical care ab
röntgenvägen 2, se-171 54
solna
SW
Manufacturer Contact
maquet critical care ab
röntgenvägen 2, se-171 54
solna 
MDR Report Key9645994
MDR Text Key189843443
Report Number8010042-2020-00054
Device Sequence Number1
Product Code BSZ
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberK160665
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberFLOW-I C30
Device Catalogue Number6677300
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2020
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/26/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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